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NCT04514627 · ClinicalTrials.gov registry record · NA

Neuromodulation With Percutaneous Electrical Nerve Field Stimulation for Adults With COVID-19

A NA study, sponsored by Olive View-UCLA Education & Research Institute.

Completed
Registry status
NA
Development phase
55
Enrollment target

NCT04514627 is a NA study that has completed, run by Olive View-UCLA Education & Research Institute. The registered enrollment target is 55 participants.

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The verdict

NCT04514627, a NA study, has completed, sponsored by Olive View-UCLA Education & Research Institute.

COMPLETED
Registry status
NA
Development phase
55 participants
Enrollment target

Study Summary

COVID-19 is a disease caused by the virus, SARS-CoV-2. Patients with this viral infection are at risk for developing pneumonia and acute respiratory distress syndrome (ARDS). Approximately 20% to 30% of hospitalized patients with COVID-19 and pneumonia require intensive care for respiratory support. Clinically, ARDS presents with severe hypoxemia evolving over several days to a week in combination with bilateral pulmonary infiltrates on chest X-ray. Widespread alveolar epithelial cell and pulmonary capillary endothelial injury can lead to severe impairment in gas exchange. In one report of 1,099 patients hospitalized with COVID-19, ARDS occurred in 15.6% of patients with severe pneumonia. In a smaller case series of 138 hospitalized patients, ARDS occurred in 19.6% of patients and in 61.1% of patients admitted to an intensive care unit (ICU). To date, no effective treatment has been established to treat COVID-19 or to prevent progression of ARDS. It is thought that a heightened immune response with an unbalanced release of inflammatory mediators in the airway is a major cause of morbidity and mortality associated with the disease. It is therefore reasonable to postulate that improved outcomes may be obtained in patients with a balanced immune response with adequate viral control and appropriate counter-regulatory immune responses whereas a poor outcome may be expected in patients with inadequate viral control or a heightened immune response or what is referred to as a "cytokine storm". Thus, modulating the pulmonary immune response without suppressing the immune system would be a viable strategy for patients with COVID-19. The current literature supports the role of neuromodulation, particularly vagal nerve stimulation (VNS), in modulating the immune response. Modulating the pro-inflammatory pathway through VNS has been demonstrated to decrease inflammatory mediators and improve outcomes in several animal models and in humans. Percutaneous electrical nerve field s

Interventions

  • DEVICE Auricular percutaneous neurostimulation

Trial Details

FieldValue
Enrollment Target 55 participants
Start Date 2020-07-13
Est. Completion 2022-03-22
Phase NA

What the Registry Record Tells You About NCT04514627

The ClinicalTrials.gov registry entry for NCT04514627 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Olive View-UCLA Education & Research Institute, which has 11 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Auricular percutaneous neurostimulation is the first listed.

NCT04514627 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04514627 about?

NCT04514627 is a clinical study titled "Neuromodulation With Percutaneous Electrical Nerve Field Stimulation for Adults With COVID-19". COVID-19 is a disease caused by the virus, SARS-CoV-2. Patients with this viral infection are at risk for developing pneumonia and acute respiratory distress syndrome (ARDS). Approximately 20% to 30% of hospitalized patients with COVID-19 and pneumonia require intensive care for respiratory support....

What is the current status of trial NCT04514627?

This trial is currently completed. It is a NA study. The enrollment target is 55 participants. The study started on 2020-07-13. Estimated completion is 2022-03-22.

What interventions are being tested in trial NCT04514627?

The interventions under investigation include: Auricular percutaneous neurostimulation (DEVICE).

Who is sponsoring clinical trial NCT04514627?

This trial is sponsored by Olive View-UCLA Education & Research Institute, which has 11 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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